The following data is part of a premarket notification filed by Seradyn Inc. with the FDA for Qms Lamotrigine Assay (reagents), Calibrators & Controls.
Device ID | K062966 |
510k Number | K062966 |
Device Name: | QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS |
Classification | Lamotrigine Assay |
Applicant | SERADYN INC. 7998 GEORGETOWN RD. SUITE 1000 Indianapolis, IN 46268 -5260 |
Contact | Jack Rogers |
Correspondent | Jack Rogers SERADYN INC. 7998 GEORGETOWN RD. SUITE 1000 Indianapolis, IN 46268 -5260 |
Product Code | ORH |
Subsequent Product Code | DLJ |
Subsequent Product Code | LAS |
CFR Regulation Number | 862.3350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-09-29 |
Decision Date | 2007-01-12 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00884883012684 | K062966 | 000 |
00884883011274 | K062966 | 000 |
00884883011267 | K062966 | 000 |
00884883011168 | K062966 | 000 |